Fouchier plans to flout Dutch export law, publish H5N1 study

Apr 17, 2012 (CIDRAP News) – Dutch flu researcher Ron Fouchier, PhD, said he intends to submit a revised manuscript of his controversial mutated-H5N1 study to Science without applying for an export permit, according to a Nature News story today.

Fouchier and colleagues at Erasmus University and a group led by Yoshihiro Kawaoka, DVM, PhD, at the University of Wisconsin have produced modified versions of H5N1 avian flu viruses that transmit readily among ferrets, which are considered good animal models for human transmission.

On Mar 30, the US National Science Advisory Board for Biosecurity (NSABB) cleared the two studies for publication in Science and Nature, after initially blocking their full publication in December over biosecurity concerns. The NSABB reversed its original decision after weighing new details on the two studies during a 2-day meeting.

Fouchier has said, however, that Dutch export controls have prevented him from submitting a revised manuscript to Science and from sharing details of his group's study publicly, according to media reports.

But he told Nature News that he plans to submit his paper to Science after an Apr 23 meeting of Dutch government officials and others without applying for an export permit.

"Science can publish any paper submitted to them, according to their [US] First Amendment right," Fouchier said. "That means that if the Dutch government would want to stop publication, they cannot do so after we formally submit to Science."

"We will not apply for an export permit, as we are convinced we do not need one," he added.

The Apr 23 meeting will include international experts in various fields, Fouchier's group, journal editors, and representatives from the World Health Organization, the European Commission, and the international Biological and Toxin Weapons Convention, the Nature story said. The meeting is designed to assess the risks and benefits of Fouchier's research.

"After this conference, and when an application [for an export permit] is received, the Dutch government will decide on an export license,” said Jan van Diepen, a spokesman for the Dutch Ministry of Economic Affairs, Agriculture, and Innovation (MEAAI), according to Nature News. He added that although the NSABB ruling will "carry weight" at the meeting, the Dutch government will decide for itself whether to allow publication.

MEAAI spokeswoman Cindy Heijdra told Nature that Fouchier could face up to 6 years in prison and $102,000 in fines for publishing the paper without seeking an export license. She said the ministry has not received a license application from his group but expects one soon.

However, it is unclear whether Fouchier's manuscript falls under export-control laws, according to the story. The Netherlands implements EU legislation for controlling exports, which requires an export permit for "dual use" information that could be used for both good and bad purposes.

EU law, though, allows exemptions for "basic scientific research" that is "not primarily directed towards a specific practical aim or objective" and for material in the public domain or necessary for patent applications.

Fouchier categorized his study as both basic scientific research and as having practical benefits for surveillance and for vaccine and antiviral drug development, the story says.

Heijdra, however, said, "A detailed analysis of the legislation, and in particular the provisions and definitions on technology transfers, have convinced us that the basic scientific research exemption is not applicable."

Fouchier remained adamant. "We simply will never apply for an export permit on a scientific manuscript for publication in a journal. We do not want to create a precedent here," he said. "We might end up in court indeed if they insist on censorship."

White House replies to congressmanIn related developments today, US Rep. Jim Sensenbrenner, R-Wis., who in early March questioned the Obama Administration's safeguards on dual-use research, released a response he received from John Holdren, PhD, who directs the White House Office of Science and Technology policy.

In his letter to Sensenbrenner dated Apr 9, Holdren wrote that the circumstances surrounding the two H5N1 papers are "unprecedented" and that although the NSABB has examined dual-use research issues for years, this is the first time the NSABB (in its original recommendation) has recommended holding back information in a research paper.

For that reason, the government hasn't needed to have a system in place to restrict dissemination, he said.

Holdren wrote that while the export regulations and international arms traffic rules can restrict the transfer outside the country of certain dual-use materials, equipment, and technology—including some intangible technology—federal officials identified serious legal and procedural hurdles that prevent the timely establishment of a mechanism for disseminating the full research reports only to selected scientists on a need-to-know basis.

He added that there were other long-term challenges with using export controls to communicate key research findings that relate to public health.

Federal officials are currently reviewing the NSABB's most recent recommendation that the two papers be published in full, he wrote.

In his March letter to Holdren, Sensenbrenner had asked why the government didn't identify the dual-use research issues earlier.

Holdren replied that the National Institutes of Health (NIH), the agency that funded the two studies, has a system for reviewing dual-use issues in its intramural research. But when the two H5N1 studies were proposed, NIH did not have a review component specifically aimed at dual-use issues. "Nonetheless, the proposed research did, prior to the award, undergo review at multiple stages," he wrote.

Sensenbrenner, in a statement today, said the Obama Administration needs to be more proactive and prepare for possible threats before they arise, and he alluded to a new federal policy released on Mar 29 addressing the oversight of life sciences dual-use research. "The new policy is a good, if belated, first step, and I will be watching its implementation closely," he said.